Cold Storage System for Storing Pharmaceutical Product Containers

Abstract

Intelligent refrigerator system for storing pharmaceutical product containers, such as vials, ampules, syringes, bottles, medication tubes, blister packs and cartons, at the point of dispensing. Embodiments of the invention use product identification technology, such as radio-frequency identification (RFID) tags and readers, to uniquely identify containers as they are added to or removed from the cold storage compartment of the refrigerator, and automatically retrieve from a local or remote database a variety of details associated with the containers and their contents, such as manufacturing data, expiration dates, time out of refrigeration, inventory levels, safety information, usage statistics, known contraindications and warnings, etc. If the details indicate that there is a problem with a particular pharmaceutical (e.g., that it is counterfeit, expired, suspect, spoiled, recalled or almost depleted), then a message or warning is automatically delivered to a human operator via an attached output device, such as a display screen, speaker or printer. Embodiments of the invention may also be configured to monitor and report temperature faults, power failures and other anomalies associated with the refrigerator or cold storage compartment.

What is claimed is: 
     
         1 . A cold storage system for pharmaceutical product containers, comprising:
 a refrigeration unit housing a cold storage compartment configured to hold a plurality of pharmaceutical product containers;   a local database for storing information associated with the plurality of pharmaceutical product containers located in the cold storage compartment;   a product identifier configured to determine a unique identifier for a pharmaceutical product container added to the cold storage compartment; and   a processor configured to determine, based on the information in the local database and the unique identifier, (i) whether the added pharmaceutical product container was previously removed from the compartment, (ii) a length of time that the added pharmaceutical product container was most recently removed from the compartment, and (iii) an updated total time out of refrigeration value for the pharmaceutical product container, wherein the processor calculates the updated total time out of refrigeration value by retrieving a prior total time out of refrigeration value from the local database and adding thereto said most recently removed length of time;   wherein the processor is further configured to modify the information in the local database to include the length of time that the added pharmaceutical product container was most recently removed and the updated total time out of refrigeration value.   
     
     
         2 . The cold storage system of  claim 1 , wherein the processor is further configured to cause a message concerning the added pharmaceutical product container to be delivered to a human operator, the message including at least one of: the unique identifier, the length of time elapsed since the added pharmaceutical product container was previously removed from the cold storage compartment, and the updated total length of time that the added pharmaceutical product container has been removed from the cold storage compartment. 
     
     
         3 . The cold storage system of  claim 1 , wherein the processor causes the message to be delivered to the human operator via at least one of: an information store, a log file, an attached output device, an email communication program, a web page server, and an online information publication service. 
     
     
         4 . The cold storage system of  claim 1 , wherein:
 the processor is electronically coupled to a clock configured to provide a current date;   the information in the local database includes a record specifying an expiration date for the added pharmaceutical product container; and   the processor is further configured to (i) determine an expiration status for the added pharmaceutical product container by comparing the current date to the expiration date, and (ii) cause a warning to be delivered to the human operator concerning the expiration status of the pharmaceutical product container.   
     
     
         5 . The cold storage system of  claim 1 , wherein:
 the information in the local database includes a record specifying a maximum time out of refrigeration value for the added pharmaceutical product container; and   the processor is further configured to (i) determine a spoliation status for the pharmaceutical product container by comparing the updated total length of time to the maximum time out of refrigeration value, and (ii) cause a warning to be delivered to the human operator concerning the spoliation status of the pharmaceutical product container.   
     
     
         6 . The cold storage system of  claim 1 , wherein:
 the processor is electronically coupled to a clock configured to provide a current time;   the information in the local database comprises a record for storing (i) a removal time indicating a time that the added pharmaceutical product was previously removed from the cold storage compartment, and (ii) a prior total length of time that the added pharmaceutical product container has been removed from the cold storage compartment; and   the processor determines the updated total length of time that the pharmaceutical product container has been removed from the cold storage compartment by retrieving the current time from the clock, retrieving the removal time and the old total length of time from the local database, subtracting the removal time from the current time to obtain a duration, and adding the duration to the prior total length of time.   
     
     
         7 . The cold storage system of  claim 1 , wherein if the processor determines that the added pharmaceutical product container was not previously removed from the cold storage compartment, then the processor will cause the time that the added pharmaceutical product container was added to the cold storage compartment to be recorded in the local database. 
     
     
         8 . The cold storage system of  claim 7 , further comprising:
 an interface to a pharmaceutical product database;   wherein the processor is further configured to (i) determine whether the pharmaceutical product database contains a set of details associated with the unique identifier, and (ii) cause a copy of the set of details to be copied from the pharmaceutical product database to the local database via the interface.   
     
     
         9 . The cold storage system of  claim 8 , wherein if the processor determines that the pharmaceutical product database does not contain a set of details associated with the unique identifier, then the processor will (i) create a record in the local database indicating that the authenticity of the pharmaceutical product container is suspect, and (ii) cause a warning to be delivered to the human operator concerning the suspect authenticity of the pharmaceutical product container. 
     
     
         10 . The cold storage system of  claim 1 , wherein the product identifier comprises an RFID reader and an antenna. 
     
     
         11 . The cold storage system of  claim 1 , wherein the product identifier comprises a barcode reader. 
     
     
         12 . A cold storage system for pharmaceutical product containers, comprising:
 a cold storage compartment configured to hold a plurality of pharmaceutical product containers;   a product identifier configured to determine a unique identifier for a pharmaceutical product container added to the cold storage compartment;   a local database comprising a record correlating the unique identifier with a prior total time out of refrigeration value for the pharmaceutical product container;   a power fail circuit for detecting a power failure condition for the refrigerator; and   a processor, electronically coupled to the product identifier, the local database and the power fail circuit, that determines a duration for the power fail condition, calculates a new total time out of refrigeration value for the pharmaceutical product container by retrieving the prior total time out of refrigeration value from the local database and adding the duration to the prior total time out of refrigeration value, and stores the new time out of refrigeration value in the local database.   
     
     
         13 . The cold storage system of  claim 12 , wherein the processor is further configured to cause a message concerning the power failure condition to be delivered to a human operator via one or more of an information store, a log file, an attached output device, an email communication, a web page server, and an online information publication service. 
     
     
         14 . A cold storage system for pharmaceutical product containers, comprising:
 a refrigeration unit housing a cold storage compartment configured to hold a plurality of pharmaceutical product containers;   a product identifier configured to determine a unique identifier for a pharmaceutical product container added to the cold storage compartment;   a local database comprising records correlating the plurality of unique identifiers with a plurality of details associated with the plurality of pharmaceutical product containers located in the cold storage compartment; and   a processor configured to determine, based on the plurality of unique identifiers and the plurality of details in the local database, whether a pharmaceutical product container has been removed from the cold storage compartment;   wherein the processor is configured to (i) record in the local database the time that the pharmaceutical product container was removed from the cold storage compartment, and (ii) cause a message to be delivered to a human operator indicating that the pharmaceutical product container was removed from the cold storage compartment; and wherein the processor is configured to determine an updated total time out of refrigeration value for the pharmaceutical product container by retrieving a prior total time out of refrigeration value from the local database and adding thereto a length of time that the pharmaceutical product container was most recently removed from the cold storage compartment.   
     
     
         15 . The cold storage system of  claim 14 , wherein the processor is further configured to determine, based on the unique identifier and the plurality of details in the local database, an expiration status for the pharmaceutical product container removed from the cold storage compartment, and cause a message concerning the expiration status to be delivered to the human operator. 
     
     
         16 . The cold storage system of  claim 14 , wherein the processor is further configured to determine, based on the unique identifier and the plurality of details in the local database, a recall status for the pharmaceutical product container removed from the cold storage compartment, and cause a message concerning the recall status to be delivered to the human operator. 
     
     
         17 . The cold storage system of  claim 14 , wherein:
 the plurality of details in the local database comprises a record indicating a specified maximum time out of refrigeration value for the pharmaceutical product container; and   the processor is further configured to determine, based on the updated total time out of refrigeration value and said specified maximum time out of refrigeration value, a spoliation status for the pharmaceutical product container removed from the cold storage compartment, and cause a message concerning the spoliation status to be delivered to the human operator.   
     
     
         18 . The cold storage system of  claim 14 , wherein:
 the cold storage compartment includes a temperature sensor that measures the temperature in the cold storage compartment; and   the processor periodically compares the temperature measured by the temperature sensor to a specified temperature value and, if the temperature differs from the specified temperature value, generates an alert concerning the temperature.   
     
     
         19 . A cold storage system for pharmaceutical product containers, comprising:
 a refrigeration unit housing a cold storage compartment configured to hold a plurality of pharmaceutical product containers;   a local database for storing information associated with the plurality of pharmaceutical product containers located in the cold storage compartment;   a product identifier configured to determine a unique identifier for a pharmaceutical product container recently removed from the cold storage compartment;   a processor configured to determine, based on the information in the local database and the unique identifier, whether there is a problem associated with the recently removed pharmaceutical product container; and   an output device, operable with the processor, to deliver a warning message to a human operator about the problem; wherein the problem comprises one or more of the following conditions: (i) the recently removed pharmaceutical product container has exceeded a maximum time out of refrigeration value, (ii) the recently removed pharmaceutical product container has been recalled; (iii) the recently removed pharmaceutical product container is suspected of being counterfeit, (iv) the pharmaceutical product inside the recently removed pharmaceutical product container has a known contraindication, (v) the pharmaceutical product inside the recently removed pharmaceutical product container has expired, and (vi) the number of pharmaceutical product containers remaining in the cold storage compartment containing the pharmaceutical product inside the recently removed pharmaceutical product container has fallen below a specified threshold.   
     
     
         20 . The cold storage system of  claim 19 , wherein the product identifier comprises an RFID reader or a barcode reader.